Routes of the same type are on the same row. Compare other markets.
11 pathway types exist in both markets: full application, new active substance, full or mixed application, known active substance, generic application, biosimilar application, conditional or accelerated approval, priority or accelerated review and more. The table lines up the routes of each type.
United States: New drug application (full, new active ingredient), 304 days. India: Permission to import or manufacture a new drug with a new molecule, 90 days. These are official targets, not actual review times.
| Pathway type | United States | India |
|---|---|---|
| Full application, new active substance | New drug application (full, new active ingredient)505(b)(1) · target 304 days · fee $4,600,753 Biologics license application (351(a))351(a) BLA · target 304 days · fee $4,600,753 | Permission to import or manufacture a new drug with a new moleculeForm CT-18 / CT-21 · target 90 days · fee ₹500,000 Vaccine approval and lot releasetarget 90 days Cell and gene therapy productstarget 90 days |
| Full or mixed application, known active substance |
Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.
New drug application relying on other data (505(b)(2))505(b)(2) · target 304 days · fee $2,300,376 |
Permission for new claims of an approved new drugForm CT-18 / CT-21, Table 3 · target 90 days Permission for a fixed dose combinationForm CT-18 / CT-21 · target 90 days · fee ₹500,000 |
| Generic application | Abbreviated new drug application (generic)505(j) ANDA · target 304 days · fee $375,684 | Permission for a new drug already approved in India (subsequent applicant)Form CT-18 / CT-21, Table 2 · target 90 days · fee ₹200,000 State manufacturing licence for drugs that are not new drugsForm 24 / Form 25 · fee ₹6,000 |
| Biosimilar application | Biosimilar application (351(k))351(k) BLA · target 304 days · fee $1,124,936 | Similar biologic (biosimilar) approvaltarget 90 days |
| Non-prescription application | - |
| Non-prescription monograph | Over-the-counter monograph orderOMOR · fee $614,608 | - |
| Conditional or accelerated approval | Accelerated approvalSecond Schedule para 1(2)(ii)(A) · target 90 days |
| Priority or accelerated review | Priority reviewtarget 183 days | Expedited reviewSecond Schedule para 1(2)(ii)(B) |
| Intensive development support designation | - |
| Rolling or phased review | - |
| Orphan or rare disease designation | Orphan drug provisionsRule 2(1)(x) · target 90 days |
| Pediatric plan or incentive | - |
| Emergency or temporary authorisation | - |
| Early or compassionate access | Import of an unapproved new drug by a government hospitalForm CT-24 / CT-25 · fee ₹10,000 Manufacture of an unapproved new drug under trial for individual patientsForm CT-26 / CT-27 · fee ₹5,000 |
| Reliance route, abridged review | - | Local clinical trial waiver for drugs approved in specified countriesRule 101 · target 90 days · relies on US, GB, JP, AU, CA, EU |
| Device: exempt or self-declared | - |
| Device: premarket notification | Premarket notification (510(k))510(k) · target 90 days · fee $28,653 |
| Device: new low or moderate risk device | De Novo classification request513(f)(2) · target 150 days · fee $191,020 | - |
| Device: premarket approval by the regulator | Premarket approval (PMA)PMA · target 180 days · fee $636,732 | Permission for a medical device without a predicateForm MD-26 / MD-27 · fee ₹100,000 · relies on GB, US, AU, CA, JP, EU Permission for a new in vitro diagnostic deviceForm MD-28 / MD-29 · fee ₹25,000 |
| Device: conformity assessment by a certification body | - | Manufacturing licence for Class A and B devicesForm MD-3 / MD-5 |
| Device: registration or licence with the regulator | - | Import licence for medical devices and IVDsForm MD-14 / MD-15 · relies on AU, CA, JP, EU, US, GB Manufacturing licence for Class C and D devicesForm MD-7 / MD-9 · target 45 days |
| Device: breakthrough or priority program | - |
| Device: humanitarian or limited population route | - |
| Other route | Registration certificate and import licence for imported drugsForm 40 / Form 41, Form 8 / Form 10 · fee ₹10,000 |